Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study intends to explore the therapeutic effect of PCSK9i Evolocumab on atherosclerotic plaques in cerebral arteries (including carotid and vertebral arteries) compared with intensive statin treatment, and monitor the pathological properties of carotid/vertebral artery plaques with OCT technology. At the same time, three-dimensional ultrasound and high-resolution magnetic resonance are used to explore the new mechanism of pathological changes of cerebral atherosclerotic plaques in a multidimensional manner.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolocumab treatment group | Experimental | Evolocumab treatment, 1ml:140mg, every 2 weeks, for 26 weeks |
|
| Intensive statin treatment group | Active Comparator | Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab 140 MG/ML | Drug | Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the thickness of fibrous cap of artery plaque measured by OCT | Changes of the thickness of fibrous cap of artery plaque measured by OCT | 27 Weeks ± 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the lipid arc of artery plaque measured by OCT | Changes of the lipid arc of artery plaque measured by OCT | 27 Weeks ± 7 days |
| Changes of the minimum lumen area (MLA) measured by OCT |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of ischemic vascular events | Occurrence of ischemic vascular events, such as TIA, acute cerebral infarction, acute myocardial infarction, etc. | 27 Weeks ± 7 days |
| Adverse events/serious adverse events |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Wan, Doctor | Contact | +8615872394527 | wanyanalan@163.com | |
| Shengcai Chen, Doctor | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bo Hu, Doctor | Union Hospital, Tongji Medical College, Huahzong University of Science and Technology | Study Chair |
| Candong Hong, Doctor | Union Hospital, Tongji Medical College, Huahzong University of Science and Technology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intensive statin treatment | Drug | Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks |
|
Changes of the minimum lumen area (MLA) measured by OCT
| 27 Weeks ± 7 days |
| Changes of lumen area stenosis measured by OCT | Changes of lumen area stenosis measured by OCT | 27 Weeks ± 7 days |
| Changes of the number of microvessels measured by OCT | Changes of the number of microvessels measured by OCT | 27 Weeks ± 7 days |
| Changes of the presence and extension of macrophages measured by OCT | Changes of the presence and extension of macrophages measured by OCT | 27 Weeks ± 7 days |
| Changes of the calcium aggregation measured by OCT | Changes of the calcium aggregation measured by OCT | 27 Weeks ± 7 days |
| Changes of arterial plaque volume measured by OCT | Changes of arterial plaque volume measured by OCT | 27 Weeks ± 7 days |
| Changes of lipid necrotic core of arterial plaque measured by OCT | Changes of lipid necrotic core of arterial plaque measured by OCT | 27 Weeks ± 7 days |
| Changes of LDL-C levels | Changes of LDL-C levels | 27 Weeks ± 7 days |
| Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound | Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound | 27 Weeks ± 7 days |
| Changes of arterial plaque volume measured by 3D-ultrasound | Changes of arterial plaque volume measured by 3D-ultrasound | 27 Weeks ± 7 days |
| Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound | Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound | 27 Weeks ± 7 days |
| Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance | Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance | 27 Weeks ± 7 days |
| Changes of arterial plaque volume measured by High resolution magnetic resonance | Changes of arterial plaque volume measured by High resolution magnetic resonance | 27 Weeks ± 7 days |
| Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance | Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance | 27 Weeks ± 7 days |
| Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.) | Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.) | 27 Weeks ± 7 days |
Adverse events/serious adverse events
| through study completion, an average of 6 months |
| Lei Zhang, Doctor | Union Hospital, Tongji Medical College, Huahzong University of Science and Technology | Principal Investigator |
| Quanwei He, Doctor | Union Hospital, Tongji Medical College, Huahzong University of Science and Technology | Principal Investigator |
| Jiehong Wu, Doctor | Union Hospital, Tongji Medical College, Huahzong University of Science and Technology | Principal Investigator |
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
Not provided
Not provided
Not provided